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Effect of Mediterranean Diets Based on Organic and Conventional Foods

17 août 2017 mis à jour par: Newcastle University

Effect of Mediterranean Diets Based on Organic and Conventional Foods on Health Related Physiological Parameters in Urine and Blood/Plasma

Results from a small number of human cohort studies are also available and indicate that there are positive associations between organic food consumption and reduced risk/incidence of certain acute diseases (e.g. pre-eclampsia, hypospadias) and obesity/overweight.

Results from animal dietary intervention studies suggest that (i) switching to organic food consumption results in significant changes in hormonal balances and an increase in immune system responsiveness and (ii) differences in pesticide residue, cadmium, protein and antioxidant concentrations between organic and conventional foods are major drivers for hormonal balances and immune system parameters in animals.

However, there is virtually no published data from (i) long-term cohort studies focusing on chronic diseases (e.g. cardiovascular disease, diabetes, cancer and neurodegenerative conditions) and (ii) controlled human dietary intervention studies comparing effects of organic and conventional diets. It is therefore currently not possible to assess whether and estimate to what extent organic food consumption may affect human health.

Aperçu de l'étude

Description détaillée

The most recent systematic literature reviews and meta-analyses have indicated significant and nutritionally-relevant composition differences between organic and conventional foods (crops, meat and dairy products). Specifically, these systematic reviews reported that:

organic crops have 17% higher antioxidant activity and between 18% and 69% higher concentrations of a range of individual antioxidants; increased intakes of polyphenolics and antioxidants has been linked to a reduced risk of certain chronic diseases such as cardiovascular and neurodegenerative diseases and certain cancers.

conventional crops have 48% higher levels of the toxic metal cadmium, and are 4-times more likely to contain detectable pesticide residues; there are general recommendations to minimise the intake of pesticides and cadmium to avoid potential negative health impacts.

conventional crops also have 15%, 10%, 30%, and 87% higher concentrations of protein, nitrogen, nitrate, nitrite, respectively; increased intakes of these compounds have been linked to both positive and negative health impacts.

organic meat, milk and dairy products have approximately 50% higher concentrations of nutritionally-desirable omega-3 fatty acids; intakes of very long chain omega-3 fatty acids in Western diets and there are EFSA recommendation to at least double their intake.

organic milk has 70% lower concentrations of iodine and slightly lower concentrations of Selenium, which is nutritionally undesirables especially in the UK where (a) the Se content of cereals has decreased (due to reduced import of cereals grown on Se-rich soil (b) Iodine fortified table salt is not widely available and used and the iodine supply relies more on mineral fortification of animal, and especially dairy feeds.

Results from a small number of human cohort studies are also available and indicate that there are positive associations between organic food consumption and reduced risk/incidence of certain acute diseases (e.g. pre-eclampsia, hypospadias) and obesity/overweight .

Results from animal dietary intervention studies suggest that (i) switching to organic food consumption results in significant changes in hormonal balances and an increase in immune system responsiveness and (ii) differences in pesticide residue, cadmium, protein and antioxidant concentrations between organic and conventional foods are major drivers for hormonal balances and immune system parameters in animals.

However, there is virtually no published data from (i) long-term cohort studies focusing on chronic diseases (e.g. cardiovascular disease, diabetes, cancer and neurodegenerative conditions) and (ii) controlled human dietary intervention studies comparing effects of organic and conventional diets. It is therefore currently not possible to assess whether and estimate to what extent organic food consumption may affect human health.

The overall aim of the study is to get a quantitative understanding of (a) the uptake (and therefore potential to affect health) of food composition components (pesticide residues, toxic metals such as cadmium, antioxidants) that differ between organic and conventional foods and (b) the effect of organic vs conventional food consumption on selected physiological parameters in plasma linked to health.

This information will be essential to (a) carry out accurate statistical power analyses (based on uptake [=estimated from blood and urine concentrations] rather than food composition data) and (b) optimise designs for longer-term dietary intervention studies, designed to identify impacts of organic food consumption on health related physiological markers in humans and mechanisms for potential health impacts.

The main objectives of the proposed study are to:

  1. Carry out a human dietary intervention study comparing the effects of switching to Mediterranean diets based on organic and conventional foods on concentrations of pesticides, toxic metals, mineral nutrients (e.g. Fe, Cu, Se, I) and antioxidants, and antioxidant activity and selected health-related markers in urine and blood.
  2. Quantify concentrations of pesticide residue, mineral, toxic metal and antioxidants in both organic and conventional food samples consumed during the intervention period
  3. Carry out both univariate and redundancy analyses to both quantify effects of different diets on urine and blood composition and to identify the most important food composition drivers for differences in urine/blood composition and health markers.

Type d'étude

Interventionnel

Inscription (Anticipé)

27

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Sivas Festos
      • Sivas, Sivas Festos, Grèce, GR 70200
        • Levidopa Field Station
    • Tyne and Wear
      • Newcastle upon Tyne, Tyne and Wear, Royaume-Uni, NE1 7RU
        • NU-Food Research Facility

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 40 ans (Adulte)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

Healthy adults No medications No known illness

Exclusion Criteria:

Any known illness Using prescribed medication Using over the counter vitamin or mineral supplements Allergy to any food

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Science basique
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Mediterranean Organic
Traditional Mediterranean diet comprised of organic ingredients
Expérimental: Mediterranean conventional
Traditional Mediterranean diet comprised of conventional ingredients

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
IL-6 in Plasma measured using ELISA
Délai: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
IL-6 in WBC measured using ELISA
Délai: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
DNA damage in WBC measured using Western Blot
Délai: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
Total antioxidant activity in plasma measured using PENTRA
Délai: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
Phenols in plasma measured using GCMS
Délai: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
Carotenoids in plasma measured using GCMS
Délai: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
Pesticides in urine and plasma measured using ICPMS
Délai: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
Isoprostanes in urine measured using ICPMS
Délai: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
toxic metals in urine and plasma (Cd, Pb, Hg, Al) measured using ICPMS
Délai: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
minerals in plasma (including Cu, Fe, Mn, Mg, Ca, I, Se) measured using ICPMS
Délai: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
Change from baseline 2 weeks post supplementation and 4 weeks post supplementation

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Collaborateurs

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 mai 2017

Achèvement primaire (Réel)

1 août 2017

Achèvement de l'étude (Anticipé)

31 décembre 2017

Dates d'inscription aux études

Première soumission

21 juin 2017

Première soumission répondant aux critères de contrôle qualité

17 août 2017

Première publication (Réel)

18 août 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

18 août 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

17 août 2017

Dernière vérification

1 août 2017

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • NUHEALTH-CS01-ORGANIC

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur État de santé

Essais cliniques sur Mediterranean Organic

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